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Organization name
UDI-DI code
Reference / catalog number

LM000096 — Class IIb MDR by LAUDA Medical GmbH &…

MD Atlas
LAUDA Medical GmbH & Co. KG

EUDAMED last updated this device on May 22, 2026

LM000096

426248181HYPODY

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LAUDA Medical GmbH & Co. KG
UDI-DI code: 04262481810219
Reference / catalog number: LM000096

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Manufacturer information

Organization name: LAUDA Medical GmbH & Co. KG
SRN: DE-MF-000027737
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Waste Electrical and Electronic Equipment Directive (WEEE Directive 2012/19/EU) Electronic Equipment - DO NOT THROW IT IN TRASH

Market distribution

Primary placement in Hungary; available across 3 countries total.

Country	On market since	Until
HungaryPrimary placement		Still on market
Bulgaria		Still on market
Romania		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262481810219
Basic UDI-DI: 426248181HYPODY
Reference / catalog number: LM000096
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The device HYPO is used to cool/heat and maintain the required temperature of a patient connected to the extracorporeal perfusion circuit (e.g. a heart-lung machine). The temperature is transferred via a heat exchanger (part of the oxygenator) in the patient's perfusion circuit (hypothermia treatment). In addition to hypothermia treatment, the device HYPO can also be used to cool a cardioplegia solution via an additional heat exchanger. The device HYPO is designed for a treatment duration of 6 hours per use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040208BODY THERMOREGULATION EQUIPMENT

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.